Medical Device Qualified Supplier Directory


HDA Technology, Inc Company Profile
E: [email protected]
T: (949) 222-9935
F: (949) 222-9929

4 Rancho Circle, Lake Forest, CA, 92630, United States
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Qualifications: ISO 13485, ISO 9001, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows

Markets Supplied: North America, Europe


HDA Technology
MEDICAL: Medical Electronic Design Company serving Southern California and the world

HDA Technology is a product development and contract manufacturing company that has been creating products for the world’s top medical device manufacturers for over 32 years. Since 1982, HDA has partnered with the world’s leading companies to develop and build innovative, lifesaving and life enhancing products.

Medical services include:

Fast-track FDA Approval

We are experts in the development, design, documentation, and regulatory compliance of new medical devices. Our knowledge of and experience with regulatory requirements, and of the processes needed to meet those standards, enables to us to design for compliance from the very start.

ISO 13485:2003 Quality

HDA specializes in developing Class I + II medical devices, with a focus on electronics, R&D, system development, and compliance. We are ISO 13485 certified for design and production.

Regulatory Compliance Experts

Our experience with medical devices includes special expertise in electromagnetic compatibility and safety.

Full-Service Medical Electronics Development

HDA can develop every aspect of your project—from concept to commercialization. We have the personnel, resources, and experience in our Irvine, California facility to develop your medical device. This may include electronics, firmware, software, prototypes and testing, achieving FDA and regulatory compliance. We can also provide manufacturing and sustaining support.

HDA Technology specializes in:

  • Inventing enabling technologies
  • Solving challenging technical problems
  • Creative and resourceful thinking
  • Attention to detail
  • On-time delivery

Our spacious engineering lab can support multiple projects concurrently, and in addition to a full suite of laboratory equipment, includes specialty equipment such as:

  • RF Screen Room and EMC test equipment
  • Power Line Simulation and Analysis Systems
  • ESD Guns
  • Fume Hood
  • Portable Chiller

Our Medical EXPERIENCE includes:

  • Oximetry
  • Electrosurgical Generators
  • Pain Management
  • RF Energy Treatment
  • Doppler Ultrasound
  • Motion Control for Surgical Devices
  • Control of Medical Chairs and Tables
  • Surgical Vacuum Systems
  • Live Image Processing
  • Neurovascular Treatment Equipment
  • Atmospheric Plasma Systems

Clients routinely come to us with great ideas, a problem to solve, or a “what if” scenario. New ideas can often be realized using existing technology, or by adapting commercial off the shelf (COTS) components, at least during the proof of concept stage. Where we shine is when something looks feasible, but has not been done successfully before. This is where research and development comes into play – when the technological side of product development calls for extraordinary creativity and ingenuity. This is our passion.

HDA Technology specializes in:

  • Inventing enabling technologies
  • Solving “impossible” problems
  • Identifying and reducing risk
  • Creating Intellectual Property
Product Development

Product development is often thought of as the process of creating a completely new product or device. Product development also applies to improving an existing product or system or to developing a concept.

  • Rapid Proof of Concept, including using commercial off the shelf (COTS) technology where appropriate. This allows you to test your idea in the real world, while keeping cost and schedule to a minimum.
  • The Right Resources: Our multidisciplinary team of engineers, experts and support staff provide complete engineering design capabilities using our ISO certified product development process. We can meet your needs for electronic and software development, electromechanical design, regulatory compliance and testing services.
  • Specialized test equipment and skills let us perform preliminary safety and compliance testing in house during development, ensuring that your product will pass compliance or qualifications testing as quickly as possible.

Electronic ServicesDesign

Whether you require a completely new design or are updating an obsolete product, HDA Technology can help you meet your product requirements for performance, quality, schedule and cost.

HDA Technology excels at transforming your idea into a working proof of concept or prototype, or a finished design – from idea to realization — in house, on time.

We are also accomplished at RF Design and at mitigating “black magic” compliance problems like ESD (electrostatic discharge) and EMI (electromagnetic interference).

Software Development

Today’s highly integrated medical electronics products incorporate advanced electronics and software technology in smaller and more complex mechanical packages than ever before. The development of embedded software must be integrated with the development of the specialized hardware for the product or device.

Crafting effective software is a cornerstone of our success. We tightly manage concurrent development of electronic, mechanical and software design with the goal of improving product quality, time-to-market, and cost.

Software is developed to a process compliant with DO-178, ISO-14971, IEC-60601-1 or other requirements as appropriate.

HDA Software Capabilities:

  • Applications software
  • DSP Algorithm Development
  • Embedded Software Development
  • Graphical User Interfaces (GUI)
  • Real-time control systems
  • Signal and Image Processing
  • Custom Test and Analysis

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HDA Technology, Inc
E: [email protected]
T: (949) 222-9935
F: (949) 222-9929

4 Rancho Circle, Lake Forest, CA, 92630, United States
View map

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